Supply and Quality Documentation definition

Supply and Quality Documentation shall have the meaning set forth in Section 4.3.
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Examples of Supply and Quality Documentation in a sentence

  • BMS shall deliver certificates of analysis, and any other documents specified in the Supply and Quality Documentation, including such documentation as is necessary to allow the Recipient to compare the BMS Study Drug certificate of analysis to the BMS Study Drug specifications.

  • In addition, the Supply and Quality Documentation shall detail the documentation required for each shipment of BMS Study Drug supplied to the Recipient or its designee for use in the Combined Therapy Clinical Trial.

  • The Supply and Quality Documentation shall outline the additional roles and responsibilities relative to the quality of BMS Study Drug in support of the Combined Therapy Clinical Trial.

  • Pursuant to the Supply and Quality Documentation, BMS shall be responsible for the regulatory compliance of the quality of the BMS Study Drug at the time the BMS Study Drug is delivered to the Recipient with the regulatory filings in the countries in the Territory where the Combined Therapy Clinical Trial will be performed.

  • Except as may be required or expressly permitted by the Protocol or the Supply and Quality Documentation, the Recipient shall not perform, and shall not allow any Third Party to perform, any analytical testing of the quantities of BMS Study Drug supplied to it under this Agreement.

  • This Agreement, including the Exhibits hereto and together with the Supply and Quality Documentation, sets forth the complete, final and exclusive agreement between the Parties concerning the subject matter hereof and supersedes all prior agreements and understandings between the Parties with respect to such subject matter.

  • Estimated supply and delivery details will be outlined in the Supply and Quality Documentation and will be updated by the Parties by mutual agreement (which agreement can be effected by the Parties’ Designated Supply contacts and without need for an amendment to this Agreement) based on the actual enrollment.

  • If the Parties jointly agree to conduct any such further clinical trials (each, a “Subsequent Study”), this Agreement and the Supply and Quality Documentation shall be amended to provide for such Subsequent Study under the terms thereof.

  • The Supply and Quality Documentation shall outline the additional roles and responsibilities relative to the quality of each Party’s Compound in support of the Combined Therapy Study.

  • The Parties shall finalize and execute the Supply and Quality Documentation within [ ]* of the Effective Date, but in no event later than the date on which the first shipment of the BMS Study Drug is supplied for use in the Combined Therapy Clinical Trial.

Related to Supply and Quality Documentation

  • Manufacturing and Supply Agreement means the Manufacturing and Supply Agreement by and between Biogen and Bioverativ, in the form attached hereto as Exhibit C.

  • Basic gas supply service means gas supply service that is

  • Gas supply service means the provision to customers of the

  • Erosion and sediment control plan or "plan" means a document containing material for the conservation of soil and water resources of a unit or group of units of land. It may include appropriate maps, an appropriate soil and water plan inventory and management information with needed interpretations, and a record of decisions contributing to conservation treatment. The plan shall contain all major conservation decisions to ensure that the entire unit or units of land will be so treated to achieve the conservation objectives.

  • Xxxxxx Agreement means that certain Contingent Stock Agreement, effective as of January 1, 1996, by The Xxxxx Company in favor of and for the benefit of the Holders (named in Schedule I thereto) and the Representatives (therein defined), as amended.

  • Manufacturing Agreement has the meaning set forth in Section 4.3.

  • Supply Agreement has the meaning set forth in Section 7.1.

  • Clinical Supply Agreement has the meaning set forth in Section 4.2.

  • Marketing Agreement means an agreement entered into, with the director, by producers, distributors, processors, or handlers pursuant to this act and binding only on those signing the agreement.

  • Transportation Service Agreement means the contract between KUB and the Customer whereby KUB agrees to provide transportation gas service to the Customer.

  • Supply Agreements has the meaning set forth in Section 7.1.

  • National Ambient Air Quality Standards or “NAAQS” means national ambient air quality standards that are promulgated pursuant to Section 109 of the Act, 42 U.S.C. § 7409.

  • General air quality operating permit or "general permit" means an air quality operating permit that meets the requirements of ARM 17.8.1222, covers multiple sources in a source category, and is issued in lieu of individual permits being issued to each source.

  • Gas supplier means a person that is duly licensed pursuant to

  • Transportation Agreement means an agreement pursuant to the Tariff under which Transporter provides Transportation or other contract services to a Shipper.

  • mobility supplement means a supplement to which paragraph 9 of Schedule 4 refers;

  • Commercial Supply Agreement has the meaning set forth in Section 5.2.

  • High quality waters means all state waters, except:

  • Supply Pipe means any part of a service pipe which a water undertaker could not be, or have been required to lay under section 46 of the Water Industry Act 1991; and

  • Data Processing Agreement means the data processing agreement located at xxx.xxxxxx.xxx/[countrycode]/legal/dpa, where “[countrycode]” means the two-letter abbreviation for the country where your Stripe Account is located.

  • Radiopharmaceutical quality assurance means, but is not limited to, the performance of appropriate chemical, biological, and physical tests on potential radiopharmaceuticals and the interpretation of the resulting data to determine their suitability for use in humans and animals, including internal test assessment, authentication of product history, and the keeping of proper records.

  • the first supplementary agreement means the agreement of which a copy is set out in the Second Schedule;

  • Air-purifying respirator means a respirator with an air-purifying filter, cartridge, or canister that removes specific air contaminants by passing ambient air through the air-purifying element.

  • Labor compliance agreement means an agreement entered into between a contractor or subcontractor and an enforcement agency to address appropriate remedial measures, compliance assistance, steps to resolve issues to increase compliance with the labor laws, or other related matters.

  • Regulatory Documentation means, with respect to the Compounds, all submissions to Regulatory Authorities in connection with the development of such Compounds, including all INDs and amendments thereto, NDAs and amendments thereto, drug master files, correspondence with regulatory agencies, periodic safety update reports, adverse event files, complaint files, inspection reports and manufacturing records, in each case together with all supporting documents (including documents that include Clinical Data).

  • Services Agreement means an agreement entered into between a Utility and one or more Affiliates for the provision of Shared Services or For Profit Affiliate Services and shall provide for the following matters as appropriate in the circumstances: